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Hematopoietic Cell Transplantation

Kidney + Stem Cell Transplant for Immune Tolerance

Phase 1 & 2
Waitlist Available
Led By Samuel Strober, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to use a reliable form of contraception for at least 24 months following transplantation
Have an HLA-matched sibling donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 12 months
Awards & highlights

Study Summary

This trial is testing whether blood stem cells, when injected after kidney transplantation and combined with lymphoid irradiation, will change the immune system such that immunosuppressive drugs can be completely withdrawn.

Who is the study for?
This trial is for kidney transplant patients at Stanford who have a healthy sibling with matching human leukocyte antigens (HLA). Participants must not have HIV, Hepatitis B or C, low white blood cell or platelet counts, high antibody levels against transplants, a history of cancer (except certain skin cancers), previous organ transplants, or allergies to rabbit proteins. They should agree to use reliable contraception for two years post-transplant.Check my eligibility
What is being tested?
The study tests if injecting the patient with their HLA-matched sibling's blood stem cells after kidney transplantation and lymphoid irradiation can eliminate the need for lifelong immunosuppressive drugs. The process involves pre-transplant donor cell collection, post-surgery radiation and anti-T cell treatment before stem cell injection. If successful, drug withdrawal starts six months later.See study design
What are the potential side effects?
Potential side effects include reactions to radiation and anti-T cell antibodies like fatigue and nausea; risks associated with stem cell injections such as infection; complications from reducing immunosuppressive drugs which may lead to organ rejection or immune system disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use birth control for at least 24 months after my transplant.
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I have a sibling who is a perfect match for a donation.
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I am not allergic to rabbit ATG or radiation treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Discontinuation of maintenance immunosuppressive drugs

Trial Design

1Treatment groups
Experimental Treatment
Group I: Immune tolerance, kidney transplantationExperimental Treatment2 Interventions
Intervention: Participants will receive hematopoietic cell transplantation and Total lymphoid irradiation. The intervention is intended to induce immune tolerance in HLA-matched living donor kidney transplantation, to allow withdrawal of the immunosuppressive drugs. Immune tolerance is achieved through the development of donor/recipient mixed chimerism following combined kidney and hematopoietic stem cell transplantation from the living donor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total lymphoid irradiation
2009
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,860 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,912 Total Patients Enrolled
1 Trials studying Immune Tolerance
30 Patients Enrolled for Immune Tolerance
Samuel Strober, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Immune Tolerance
30 Patients Enrolled for Immune Tolerance

Media Library

Hematopoietic Cell Transplantation (Hematopoietic Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT00319657 — Phase 1 & 2
Hematopoietic Cell Transplantation (Hematopoietic Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00319657 — Phase 1 & 2
Immune Tolerance Research Study Groups: Immune tolerance, kidney transplantation
Immune Tolerance Clinical Trial 2023: Hematopoietic Cell Transplantation Highlights & Side Effects. Trial Name: NCT00319657 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this research opportunity available?

"In order to be eligible for this trial, applicants must have achieved immune tolerance and fall between 18-60 years of age. Furthermore, they need to have had a kidney transplant at Stanford University Medical Center as well as commit to using contraception for two full years post-transplantation."

Answered by AI

Is this experiment open to enrollees who are octogenarians?

"According to the requirements for enrolment, only those aged 18 and over who are younger than 60 may participate in this experiment."

Answered by AI

Are there any vacancies remaining in this medical experiment?

"An examination of the clinicaltrials.gov website reveals that this particular medical trial, which was created on July 1st 2004 and last updated June 15th 2021 is not currently enrolling patients. Nonetheless, there are 5 other studies actively recruiting participants at present."

Answered by AI
Recent research and studies
~2 spots leftby Jul 2026